Pulmonary Cystic FibrosisNCT04095078
Ancillary Home Airway Clearance in CF Patients ( HomeCareSIMEOX )
A study testing SIMEOX in people with Pulmonary Cystic Fibrosis, run by Physio-Assist at 5 sites in France.
Trial summary
Regular bronchial clearance is essential in patients with cystic fibrosis for their bronchial health. SIMEOX® (Physio-Assist, Aix en Provence, France) is an innovative medical device for the drainage of the bronchial tree. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Pulmonary Cystic Fibrosis
- What is being tested?
- SIMEOX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 5 sitesFrance
- Study dates
- 10 Mar 2020to 15 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- one of the 56 first patients of HOME-CARE SIMEOX study
- same criteria as HOME-CARE SIMEOX study
Who cannot join
- same criteria as HOME-CARE SIMEOX study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Grenoble University Hospital : pneumo-pediatric department
Grenoble, 38043
Grenoble University-Affiliated Hospital : Pneumology department
Grenoble, 38043
Montpellier Hospital Center
Montpellier, 34000
Nice University-Affiliated Hospital : Pneumology department
Nice, 06002
Nice University-Affiliated Hospital : Pneumo-pediatric department
Nice, 06200
About this study
Official title: Efficiency and Acceptability of SIMEOX® Used Autonomously at Home for Bronchial Clearance in Patients With Cystic Fibrosis: Ancillary Study
Regular bronchial clearance is essential in patients with cystic fibrosis for their bronchial health. SIMEOX® (Physio-Assist, Aix en Provence, France) is an innovative medical device for the drainage of the bronchial tree. By changing the rheological properties of mucus, SIMEOX® helps to mobilize secretions and assists their transport to the upper airways. This technology is based on fundamental research on bronchial mucus rheology. At the present time, SIMEOX® device is mainly used over a short period at the time or after an exacerbation in healthcare structures (hospitals, physiotherapy practices, postcare, and rehabilitation units, etc…). The clinical effects observed in the short term encourages long-term autonomous use by the patients themselves. The overall objective of this study is to evaluate the efficiency and acceptability of SIMEOX® used at home by the patient himself for bronchial clearance in patients with cystic fibrosis.
- Conditions
- Pulmonary Cystic Fibrosis
- Being tested
- SIMEOX
- Keywords
- bronchial clearance, cystic fibrosis
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIMEOXDevice
Use without obligation, in autonomous and at home of the bronchial clearance device: SIMEOX
| Study group | Role | What they receive |
|---|---|---|
| SIMEOX | Experimental | Use the device for 3 months in addition to usual care Receives: Device: SIMEOX |
| Control | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary static hyperinflation assessed by residual volume
Relative variation in Pulmonary residual volume in the SIMEOX® treated group versus control group.
Measured: Change from baseline at 3 months
Secondary outcomes (4)
Use assessed by the duration of use of SIMEOX® device
Assess the duration of uses of the device SIMEOX by the patient in the SIMEOX® treated group to assess the use by patient of the device.
Measured: During 3 months of use
Inspiratory capacity
Relative variation of Inspiratory capacity in liter in the SIMEOX® treated group versus control group
Measured: Change from baseline at 3 months
Residual functional capacity (RFC)
Relative variation of Residual functional capacity (RFC) in liter in the SIMEOX® treated group versus control group
Measured: Change from baseline at 3 months
Total lung capacity (TLC)
Relative variation of Total lung capacity (TLC) in liter in the SIMEOX® treated group versus control group
Measured: Change from baseline at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start10 Mar 2020
- Primary completion15 Sep 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, controlled, multicenter trial
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Physio-Assist
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Icadom
- Responsible party
- Sponsor
- Investigators
- Boubou Camara, MD, Principal investigator, CHUGA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095078
- Sponsor's protocol ID
- Ancillary Home-Care SIMEOX
- Status last verified
- Jan 2022
- First submitted
- 17 Sep 2019
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency and Acceptability of SIMEOX® Used Autonomously at Home for Bronchial Clearance in Patients With Cystic Fibrosis: Ancillary Study
- ClinicalTrials.gov ID
- NCT04095078
- Acronym / sponsor ID
- Ancillary Home-Care SIMEOX
- Conditions
- Pulmonary Cystic Fibrosis
- Keywords
- bronchial clearance, cystic fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Physio-AssistIndustry (pharma, biotech, devices)
- Collaborators
- Icadom
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 19 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Regular bronchial clearance is essential in patients with cystic fibrosis for their bronchial health. SIMEOX® (Physio-Assist, Aix en Provence, France) is an innovative medical device for the drainage of the bronchial tree. By changing the rheological properties of mucus, SIMEOX® helps to mobilize secretions and assists their transport to the upper airways. This technology is based on fundamental research on bronchial mucus rheology. At the present time, SIMEOX® device is mainly used over a short period at the time or after an exacerbation in healthcare structures (hospitals, physiotherapy practices, postcare, and rehabilitation units, etc…). The clinical effects observed in the short term encourages long-term autonomous use by the patients themselves. The overall objective of this study is to evaluate the efficiency and acceptability of SIMEOX® used at home by the patient himself for bronchial clearance in patients with cystic fibrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, controlled, multicenter trial
| Arm | Type | Receives |
|---|---|---|
| SIMEOX | Experimental | Device: SIMEOXUse the device for 3 months in addition to usual care |
| Control | No intervention | –Usual care |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- one of the 56 first patients of HOME-CARE SIMEOX study
- same criteria as HOME-CARE SIMEOX study
Key exclusion criteria (1 listed)
- same criteria as HOME-CARE SIMEOX study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIMEOXUse without obligation, in autonomous and at home of the bronchial clearance device: SIMEOX | Device | SIMEOX |
Primary outcome
Pulmonary static hyperinflation assessed by residual volume
Time frame: Change from baseline at 3 months
Relative variation in Pulmonary residual volume in the SIMEOX® treated group versus control group.
4 secondary outcomes
Use assessed by the duration of use of SIMEOX® device
Time frame: During 3 months of use
Inspiratory capacity
Time frame: Change from baseline at 3 months
Residual functional capacity (RFC)
Time frame: Change from baseline at 3 months
Total lung capacity (TLC)
Time frame: Change from baseline at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boubou Camara, MD principal investigator
CHUGA
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIMEOX in people with Pulmonary Cystic Fibrosis, run by Physio-Assist at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary static hyperinflation assessed by residual volume (time frame: Change from baseline at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.